Glossary entry (derived from question below)
English term or phrase:
CTA
Spanish translation:
Autorización de ensayos clínicos
Added to glossary by
Mónica Belén Colacilli
Jul 9, 2005 21:39
18 yrs ago
56 viewers *
English term
Argentina
Translator since 2003, Medicine Student
Native in: Spanish (Variants: Argentine, Latin American) 
Works in: English to Spanish, Spanish to English, Spanish
CTA
English to Spanish
Science
Medical (general)
informed consent
Request for "CTAs" on a medicinal product for human use.
Protocol Number: xxx
Protocol Title: A Randomized Trial Comparing Preservation of Function Status After Either xx® Electroporation with Intraumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent or Second Primary Squamous Cell Carcinoma...
Protocol Number: xxx
Protocol Title: A Randomized Trial Comparing Preservation of Function Status After Either xx® Electroporation with Intraumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent or Second Primary Squamous Cell Carcinoma...
Proposed translations
+2
6 mins
Victor Kripper
Argentina
Argentina
Native in Spanish
Specializes in field
Argentina
MEDICAL DOCTOR + MEDICAL AND PHARMACEUTI
Native in: Spanish
Works in: English to Spanish, Spanish to English, Spanish, and 1 more.
Related KudoZ points
:
60
Selected
Autorización de ensayos clínicos
Clinical Trial Authorisation (CTA)
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Note added at 8 mins (2005-07-09 21:47:46 GMT)
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http://bvs.sld.cu/revistas/far/vol36_s_02/I PUBLICACIONES AS...
Evaluar el comportamiento de las solicitudes de Autorización de Ensayos Clínicos (AEC)....
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Note added at 9 mins (2005-07-09 21:48:54 GMT)
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www.cecmed.sld.cu/Docs/Infocecmed/Boleno42.pdf
... La Autorización de Ensayos Clínicos (AEC) en sus diferentes fases (I, II, III) se inicia en ... tramites de Registro y Autorización de. Ensayos Clínicos en Humanos ...
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Note added at 8 mins (2005-07-09 21:47:46 GMT)
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http://bvs.sld.cu/revistas/far/vol36_s_02/I PUBLICACIONES AS...
Evaluar el comportamiento de las solicitudes de Autorización de Ensayos Clínicos (AEC)....
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Note added at 9 mins (2005-07-09 21:48:54 GMT)
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www.cecmed.sld.cu/Docs/Infocecmed/Boleno42.pdf
... La Autorización de Ensayos Clínicos (AEC) en sus diferentes fases (I, II, III) se inicia en ... tramites de Registro y Autorización de. Ensayos Clínicos en Humanos ...
4 KudoZ points awarded for this answer.
Comment: "¡Muchas gracias a todos!"
10 mins
Xenia Wong
Native in English
&
Spanish
Works in field
Excellence-promptness-guarantee-20 yrs.
Native in: Spanish 
, English
Works in: English to Spanish, Spanish to English
Related KudoZ points
:
282
autorización para ensayos clínicos / acuerdos para ensayos clínicos
Es lo que encontré....ojalá te sirva.
Clinical Trial Authorisation (UK)
Clinical Trials Agreement
Clinical Trial Authorisation (UK)
Clinical Trials Agreement
6 mins
clinical trial application
xx
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Note added at 8 mins (2005-07-09 21:47:19 GMT)
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http://www.medilexicon.com/
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Note added at 9 mins (2005-07-09 21:48:48 GMT)
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Solicitud de autorización para estudios clícos
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Note added at 15 mins (2005-07-09 21:54:23 GMT)
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European Clinical Trial Database
Welcome to EudraCT - [ Traduzca esta página ]
If you have saved the Clinical Trial Application to disk and wish to load the details please use ... Click here to load a saved Clinical Trial Application ...
https://eudract.emea.eu.int/eudract/index.do - 15k - 8 Jul 2005
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Note added at 17 mins (2005-07-09 21:56:46 GMT)
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Outlined in the guidance are the **Clinical Trial Application (CTA)** and Clinical Trial Application- Amendment (CTA-A) requirements for the sale and importation of drugs for use in human clinical trials in Canada [C.05.006(1) and C.05.008]. Prior to the initiation of a clinical trial conducted with drugs in humans in Canada, sponsors must file a CTA or CTA-A to Health Canada and receive a No Objection Letter (NOL) or not be issued a Notice in respect of the drug, which indicates that ...
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ctd_cta_notice_e.h...
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Note added at 20 mins (2005-07-09 22:00:02 GMT)
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En el RU lo llaman Clinical Trial Authorisation
http://medicines.mhra.gov.uk/ourwork/licensingmeds/types/cli...
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Note added at 26 mins (2005-07-09 22:05:51 GMT)
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Genmab and Medarex Announce Filing of A Clinical Trial Application for Humax-Inflam/Mdx018.
COPENHAGEN, Denmark, and PRINCETON, N.J., Dec. 10 /PRNewswire-
FirstCall/ -- Genmab A/S (CSE:GEN and FSE: GE9D) and Medarex, Inc. (Nasdaq: MEDX) today announced the filing of a **clinical trial
application (CTA)** in Europe for HuMax-Inflam, also known as MDX-018, for use in the treatment of an autoimmune disease. **A CTA filing is the equivalent of an investigational new drug (IND) application in the United States** and is a request to the regulatory authorities in Europe to seek approval to conduct a clinical study in patients.
http://www.medarex.com/cgi-local/item.pl/20021210-555550
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Note added at 8 mins (2005-07-09 21:47:19 GMT)
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http://www.medilexicon.com/
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Note added at 9 mins (2005-07-09 21:48:48 GMT)
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Solicitud de autorización para estudios clícos
--------------------------------------------------
Note added at 15 mins (2005-07-09 21:54:23 GMT)
--------------------------------------------------
European Clinical Trial Database
Welcome to EudraCT - [ Traduzca esta página ]
If you have saved the Clinical Trial Application to disk and wish to load the details please use ... Click here to load a saved Clinical Trial Application ...
https://eudract.emea.eu.int/eudract/index.do - 15k - 8 Jul 2005
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Note added at 17 mins (2005-07-09 21:56:46 GMT)
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Outlined in the guidance are the **Clinical Trial Application (CTA)** and Clinical Trial Application- Amendment (CTA-A) requirements for the sale and importation of drugs for use in human clinical trials in Canada [C.05.006(1) and C.05.008]. Prior to the initiation of a clinical trial conducted with drugs in humans in Canada, sponsors must file a CTA or CTA-A to Health Canada and receive a No Objection Letter (NOL) or not be issued a Notice in respect of the drug, which indicates that ...
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/ctd_cta_notice_e.h...
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Note added at 20 mins (2005-07-09 22:00:02 GMT)
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En el RU lo llaman Clinical Trial Authorisation
http://medicines.mhra.gov.uk/ourwork/licensingmeds/types/cli...
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Note added at 26 mins (2005-07-09 22:05:51 GMT)
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Genmab and Medarex Announce Filing of A Clinical Trial Application for Humax-Inflam/Mdx018.
COPENHAGEN, Denmark, and PRINCETON, N.J., Dec. 10 /PRNewswire-
FirstCall/ -- Genmab A/S (CSE:GEN and FSE: GE9D) and Medarex, Inc. (Nasdaq: MEDX) today announced the filing of a **clinical trial
application (CTA)** in Europe for HuMax-Inflam, also known as MDX-018, for use in the treatment of an autoimmune disease. **A CTA filing is the equivalent of an investigational new drug (IND) application in the United States** and is a request to the regulatory authorities in Europe to seek approval to conduct a clinical study in patients.
http://www.medarex.com/cgi-local/item.pl/20021210-555550
Peer comment(s):
| neutral |
Gabriela Mejías
: Dear Maria, I agree with the meaning, but the translation?
6 hrs
|
|
Gracias Gabriela, la puse abajo: Solicitud de autorización para estudios clínicos
|
37 mins
Marcelo González
United States
United States
Native in English
United States
PhD in Translation Studies
Native in: English (Variant: US)
Works in: Spanish to English, English to Spanish
Related KudoZ points
:
33
consentimiento para participar en ensayos/investigaciones/estudios clínicos
La realización de investigaciones clínicas con productos sanitarios en España se
... demás su consentimiento para participar en la investigación clínica, ...
www.msc.es/profesional/farmacia/ legislacion/Pdf/circular_3_01.pdf
pero sólo indirectamente en investigaciones clínicas ... ¿Cómo y en que términos
les será pedido su consentimiento para participar en el estudio? ...
www.uchile.cl/bioetica/doc/normas.pps
pidiéndoseles su consentimiento para participar en ella. ... En la tabla N 1
se muestran las variables clínicas y demográficas de los pacientes. ...
www.scielo.org.pe/ scielo.php?pid=S1018-130X2003000400005&script=sci_arttext&tlng=e
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Note added at 40 mins (2005-07-09 22:19:16 GMT)
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Another option might be \"consentimiento clínico\" :-)
JEFE DEL SERVICIO:.... CONSENTIMIENTO CLINICO-QUIRURGICO INFORMADO. ...
www.infoleg.gov.ar/txtnorma/66973.htm
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Note added at 43 mins (2005-07-09 22:22:47 GMT)
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Or \"consentimiento a investigaciones (o experimentos)\"
sometido sin su libre consentimiento a investigaciones o experimentos médicos.
... En consecuencia, a partir de marzo de 1995, las clínicas y centros de ...
www.unhchr.ch/tbs/doc.nsf/ (Symbol)/CCPR.C.74.Add.3.Sp?Opendocument
... demás su consentimiento para participar en la investigación clínica, ...
www.msc.es/profesional/farmacia/ legislacion/Pdf/circular_3_01.pdf
pero sólo indirectamente en investigaciones clínicas ... ¿Cómo y en que términos
les será pedido su consentimiento para participar en el estudio? ...
www.uchile.cl/bioetica/doc/normas.pps
pidiéndoseles su consentimiento para participar en ella. ... En la tabla N 1
se muestran las variables clínicas y demográficas de los pacientes. ...
www.scielo.org.pe/ scielo.php?pid=S1018-130X2003000400005&script=sci_arttext&tlng=e
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Note added at 40 mins (2005-07-09 22:19:16 GMT)
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Another option might be \"consentimiento clínico\" :-)
JEFE DEL SERVICIO:.... CONSENTIMIENTO CLINICO-QUIRURGICO INFORMADO. ...
www.infoleg.gov.ar/txtnorma/66973.htm
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Note added at 43 mins (2005-07-09 22:22:47 GMT)
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Or \"consentimiento a investigaciones (o experimentos)\"
sometido sin su libre consentimiento a investigaciones o experimentos médicos.
... En consecuencia, a partir de marzo de 1995, las clínicas y centros de ...
www.unhchr.ch/tbs/doc.nsf/ (Symbol)/CCPR.C.74.Add.3.Sp?Opendocument
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